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Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.
Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.
At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.
The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.
The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.
The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)
The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
Outcomes similar for both groups
The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).
In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.
The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.
Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.
For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
Research results have been mixed
Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”
The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.
Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.
Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.
In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
Expert: This study unlikely to change minds
In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.
This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”
Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.
He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”
Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.
“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”
He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.
“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.
This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.
Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.
Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.
At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.
The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.
The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.
The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)
The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
Outcomes similar for both groups
The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).
In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.
The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.
Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.
For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
Research results have been mixed
Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”
The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.
Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.
Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.
In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
Expert: This study unlikely to change minds
In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.
This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”
Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.
He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”
Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.
“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”
He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.
“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.
This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.
Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.
Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.
At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.
The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.
The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.
The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)
The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
Outcomes similar for both groups
The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).
In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.
The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.
Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.
For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
Research results have been mixed
Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”
The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.
Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.
Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.
In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
Expert: This study unlikely to change minds
In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.
This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”
Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.
He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”
Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.
“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”
He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.
“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.
This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.
FROM OBSTETRICS & GYNECOLOGY